FDA reform legislation nears passage

The House of Representatives last week passed its version of legislation that would reform the Food and Drug Administration, setting the stage for what would be the biggest overhaul of the agency in years. The legislation is intended to speed up the review of medical drugs and devices, and includes provisions for allowing third parties to review 510(k) applications of low- and medium-risk devices.

The House acted on its version of FDA reform on Oct. 7, passing the bill by a wide margin. The Senate passed its own legislation Sept. 24, and the bills will go to conference committee later this month to iron out differences before being sent to President Clinton for his signature.

Major provisions in the legislation include an expansion of the FDA's third-party device review pilot program, as well as a renewal of the pharmaceutical user fees that have allowed the agency to hire hundreds of additional employees to speed up drug reviews. Another provision in the Senate bill would remove the FDA's authority to regulate radioisotopes produced in cyclotrons for PET imaging, which has been a point of contention between PET advocates and the FDA. Differences between the bills include provisions concerning the FDA's ability to regulate devices for uses other than those intended by the manufacturer.

As FDA reform neared passage, the agency's Center for Devices and Radiological Health released data that show it has improved its review turnaround times. During the 1997 fiscal year, CDRH took an average of 97 days to review 510(k) submissions, according to the agency. That represents an improvement over the average time of 110 days reported last year and 184 days during the 1994 fiscal year.

In the first three quarters of this fiscal year, 98% of 510(k) submissions received an initial review decision in 90 days or less, compared with 93% last year and 68% for the 1994 fiscal year. The agency credited management initiatives, including improved communication with manufacturers during the planning of clinical studies, for the sharp reduction of review times.

The CDRH has also eliminated its backlog for premarket approval applications (PMAs). In addition, CDRH approved 48 PMAs during the fiscal year. In fiscal year 1996, it approved 43 applications.